This randomized, double-blind, placebo-controlled study (n=160) aims to evaluate the safety, tolerability, and efficacy of Psilocybin-Assisted Psychotherapy (APEX-002-A02) in treating severe depression among adults with Post-Traumatic Stress Disorder (PTSD).
Post-Traumatic Stress Disorder (PTSD) often coexists with depression and other psychiatric conditions, presenting a significant healthcare challenge. Traditional treatments often have limited efficacy and may be associated with adverse effects. Psilocybin, a compound found in certain mushrooms, has shown promise in treating depression and other symptoms associated with PTSD. This study seeks to further explore its therapeutic potential.
Participants, aged between 18 and 65, who meet DSM-5 criteria for current PTSD with symptoms lasting at least six months and have moderate PTSD and severe depression, will be recruited. They must also be fluent in English or French and willing to provide informed consent. Exclusion criteria include pregnancy, certain medical conditions, substance use disorders, and previous exposure to psilocybin beyond specified limits.
The study will employ a randomised allocation, with one group receiving APEX-002-A02 (psilocybin) and the other receiving a placebo. Both groups will undergo quadruple masking, where participants, care providers, investigators, and outcome assessors are unaware of the treatment allocation. Outcome measures include the incidence of adverse events, changes in severity of depressive symptoms, PTSD symptoms, anxiety, suicidal ideation and behaviour, and chronic pain severity.
The primary outcome measures will be assessed from baseline to day 140, while secondary outcome measures will be assessed at various intervals up to day 140. The study is estimated to start in December 2023 and conclude in June 2025, with an estimated enrolment of 160 participants.
This study is sponsored by Apex Labs Ltd. and aims to address the need for effective and safe treatments for severe depression in individuals with PTSD, potentially offering a novel therapeutic approach for this challenging condition.
Trial Details
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is often accompanied by other psychiatric and physical comorbidities, both of which are associated with elevated healthcare costs. Depression, psychosis and suicide rates are consistently reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and comorbid depression, there is a shortfall of effective treatments with few side effects that target the broad range of symptoms, including depression. Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating safety and efficacy for a variety of indications, with no significant adverse events occurring during the course of treatment and follow-up. Notably, in a participant group distinguished by long-standing, moderate to severe major depressive disorder, two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression. Based on previous research, psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence. Furthermore, the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions.NCT Number NCT06141876